Request a Government Accountability Office (GAO) report examining the FTC’s waste of taxpayer dollars related to U.S. (FTC) vs Bayer Corp.
Under the Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Trade Commission (FTC) regulates the advertising of dietary supplements and foods, determines whether ads labeling and testimonials are truthful and not misleading, and whether they are substantiated by competent and reliable scientific evidence. The Food and Drug Administration (FDA), on the other hand, regulates labeling and determines when statements are permitted structure/function claims or unpermitted disease claims.
While the FTC has increased action against dietary supplement companies making claims on product labels, they continue to overreach and enforce a mythical requirement, two randomized, placebo-controlled, clinical trials (RCT’s) on all claims. This requirement while found in consent decrees, is not written anywhere in food law or FTC’s or FDA’s substantiation standard of what constitutes competent and reliable scientific evidence for foods and supplements.
NPA is concerned that the FTC is unfairly imposing a two RCT rule on companies making structure function claims. In their attempt to apply this standard for competent and reliable scientific evidence, FTC has overly burdensome mandated a two RCT requirement on the back end of consent decrees, rather than through public notice and comment rulemaking. This two RCT rule for supplement claims, a pharmaceutical requirement, is in violation of the Administrative Procedure Act.
In 2015, US District Court of New Jersey (U.S. (FTC) vs. Bayer Corp.) ruled to not hold Bayer in contempt for structure function claims made by the supplement company in support of one of its colon health dietary supplement products. NPA submitted two amicus briefs, and NPA was the only association whose comments were quoted in the final decision, which ultimately supported Bayer. Bayer had multiple lines of substantiation for its colon health products, but FTC still chose to pursue a frivolous lawsuit alleging they had inadequate evidence.
Had the court ruled in favor of the FTC, thereby requiring two RCT studies, the economic impact for dietary supplement consumers and manufacturers would have been devastating. Consumer choice would have been curtailed, as manufacturers would have devoted less time and resources to product innovation.
Currently, it takes 10 to 15 years to bring a new drug to the marketplace. These time frames would destroy all supplement innovation. Additionally, under these requirements, companies bringing novel dietary ingredients to the marketplace would have to pay the same costs for making structure function claims as drug companies do for drug claims but would receive no intellectual property protection to recoup their investment costs.
The fact is, with a long history of safe use by millions of consumers, there should be no requirement for two RCTs on structure function claims. It is well-known that calcium builds strong bones, and the requirements already in place are more than ample to back up this claim.
NPA welcomes regulatory action from the FTC when appropriate, within the agency’s boundaries that do not violate the Dietary Supplement Health and Education Act (DSHEA) or the FFDCA. However, the recent case of Bayer vs. FTC showed that companies with good science do not need two RCT’s to demonstrate substantiation to a Federal court. Furthermore, these cases are a huge waste of tax-payer dollars.
NPA will continue to strongly oppose any FTC requirement of two RCTs, as there is no legal basis or other scientific justification to mandate this requirement as a rule of general applicability.